Estrogen Exposure and Atherosclerosis in Postmenopausal Women

April 3, 2020 updated by: Antonio Cano Sanchez, University of Valencia

Exposure to Endogenous Estrogens and Imaging Parameters of Atherosclerosis Burden in Postmenopausal Women

One hundred Spanish postmenopausal women accepted to be investigated for cardiovascular risk actors including clinical features, serum biochemical parameters, single nucleotide polymorphisms for estrogen receptor, and imaging parameters, carotid intima-media thickness (91 women) and coronary computed tomography (32 women). Multivariable analysis confirmed that both age and glucose level directly affected IMT. Estrogenic exposure, as measured by the allele associated with lower expression of the ER beta gene, was protective at the sinus and the wall. Findings at the coronary arteries, either moderate or high calcium index (CAC) and/or significant lumen stenosis were sporadic and did not allow for establishing association with any of the variables assessed.

Study Overview

Status

Completed

Conditions

Detailed Description

One hundred postmenopausal women living in the urban area of Valencia were invited to participate in a cross-sectional study in which a list of clinical and analytical risk factors for cardiovascular disease were assessed. Clinical factors included weight, waist circumference, body mass index and blood pressure. Analytical parameters included lipidogram, serum glucose and insulin, thyroid hormones (TSH and total T4), vitamin D, ultra-sensitive C-reactive protein, estradiol, and osteoprotegerin. Imaging studies were performed to identify the atherosclerotic burden at the carotid artery (intima-media thickness, measured by a high frequency ultrasound probe), and the coronaries (both coronary artery calcium(CAC) score and the degree of lumen stenosis). Genetic susceptibility was measured by studying single nucleotide polymorphisms of the estrogen receptor. The independent effect of each variable was analyzed with multivariate analysis.

Study Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Postmenopausal women attending a clinical outpatient service in a third-level hospital for health control.

Description

Inclusion Criteria:

  • Postmenopausal women free of previous diagnosis of cardiovascular disease, Caucasian ethnicity, urban origin, medium or medium-low socioeconomic extraction.

Exclusion Criteria:

  • Previous diagnosis of cardiovascular disease, inability to understand the purpose and conditions of the study..

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Postmenopausal women
Postmenopausal women attending the outpatient service of a third level hospital for health control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carotid intima-media thickness.
Time Frame: 12 weeks
Postmenopausal women attending clinical service for health control were measured carotid intima-media thickness by ultrasound.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in coronary calcium score.
Time Frame: 12 weeks
Postmenopausal women attending clinical service for health control were measured the coronary calcium score with computed tomography.
12 weeks
Changes in coronary lumen stenosis.
Time Frame: 12 weeks
Postmenopausal women attending clinical service for health control were measured the coronary lumen stenosis with computed tomography.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Investigators

  • Principal Investigator: Antonio Cano, MD, University of Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 23, 2016

First Submitted That Met QC Criteria

October 30, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ayudas Fundación Eresa 2008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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